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Oesophageal Electrode Probe and Device for Cardiological Treatment and/or Diagnosis (US20200261024)
(2020)
An oesophageal electrode probe for bioimpedance measurement and/or for neurostimulation is provided; a device for transoesophageal cardiological treatment and/or cardiological diagnosis is also provided; a method for the open-loop or closed-loop control of a cardiological catheter ablation device and/or a cardiological, circulatory and/or respiratory support device is also provided. The oesophageal electrode probe comprises a bioimpedance measuring device for measuring the bioimpedance of at least one part of tissue surrounding the oesophageal electrode probe. The bioimpedance device comprises at least one first and one second electrode. The at least one first electrode is arranged on a side of the oesophageal electrode probe facing towards the heart. The at least one second electrode is arranged on a side of the oesophageal electrode probe facing away from the heart. The device comprises the oesophageal electrode probe and a control and/or evaluation device.
A disturbed synchronization of the ventricular contraction can cause a highly developed systolic heart failure in affected patients with reduction of the left ventricular ejection fraction, which can often be explained by a diseased left bundle branch block (LBBB). If medication remains unresponsive, the concerned patients will be treated with a cardiac resynchronization therapy (CRT) system. The aim of this study was to integrate His-bundle pacing into the Offenburg heart rhythm model in order to visualize the electrical pacing field generated by His-Bundle-Pacing. Modelling and electrical field simulation activities were performed with the software CST (Computer Simulation Technology) from Dessault Systèms. CRT with biventricular pacing is to be achieved by an apical right ventricular electrode and an additional left ventricular electrode, which is floated into the coronary vein sinus. The non-responder rate of the CRT therapy is about one third of the CRT patients. His- Bundle-Pacing represents a physiological alternative to conventional cardiac pacing and cardiac resynchronization. An electrode implanted in the His-bundle emits a stronger electrical pacing field than the electrical pacing field of conventional cardiac pacemakers. The pacing of the Hisbundle was performed by the Medtronic Select Secure 3830 electrode with pacing voltage amplitudes of 3 V, 2 V and 1,5 V in combination with a pacing pulse duration of 1 ms. Compared to conventional pacemaker pacing, His-bundle pacing is capable of bridging LBBB conduction disorders in the left ventricle. The His-bundle pacing electrical field is able to spread via the physiological pathway in the right and left ventricles for CRT with a narrow QRS-complex in the surface ECG.
Introduction: Patient selection for cardiac resynchronization therapy (CRT) requires quantification of left ventricular conduction delay (LVCD). After implantation of biventricular pacing systems, individual AV delay (AVD) programming is essential to ensure hemodynamic response. To exclude adverse effects, AVD should exceed individual implant-related interatrial conduction times (IACT). As result of a pilot study, we proposed the development of a programmer-based transoesophageal left heart electrogram (LHE) recording to simplify both, LVCD and IACT measurement. This feature was implemented into the Biotronik ICS3000 programmer simultaneously with 3-channel surface ECG.
Methods: A 5F oesophageal electrode was perorally applied in 44 heart failure CRT-D patients (34m, 10f, 65±8 yrs., QRS=162±21ms). In position of maximum left ventricular deflection, oesophageal LVCD was measured between onsets of QRS in surface ECG and oesophageal left ventricular deflection. Then, in position of maximum left atrial deflection (LA), IACT in VDD operation (As-LA) was calculated by difference between programmed AV delay and the measured interval from onset of left atrial deflection to ventricular stimulus in the oesophageal electrogram. IACT in DDD operation (Ap-LA) was measured between atrial stimulus and LA..
Results: LVCD of the CRT patients was characterized by a minimum of 47ms with mean of 69±23ms. As-LA and Ap-LA were found to be 41±23ms and 125±25ms, resp., at mean. In 7 patients (15,9%), IACT measurement in DDD operation uncovered adverse AVD if left in factory settings. In this cases, Ap-LA exceeded the factory AVD. In 6 patients (13,6%), IACT in VDD operation was less than or equal 10ms indicating the need for short AVD.
Conclusion: Response to CRT requires distinct LVCD and AVD optimization. The ICS3000 oesophageal LHE feature can be utilized to measure LVCD in order to justify selection for CRT. IACT measurement simplifies AV delay optimization in patients with CRT systems irrespective of their make and model.
Introduction: To simplify AV delay (AVD) optimization in cardiac resynchronization therapy (CRT), we reported that the hemodynamically optimal AVD for VDD and DDD mode CRT pacing can be approximated by individually measuring implant-related interatrial conduction intervals (IACT) in oesophageal electrogram (LAE) and adding about 50ms. The programmer-based St Jude QuickOpt algorithm is utilizing this finding. By automatically measuring IACT in VDD operation, it predicts the sensed AVD by adding either 30ms or 60ms. Paced AVD is strictly 50ms longer than sensed AVD. As consequence of those variations, several studies identified distinct inaccuracies of QuickOpt. Therefore, we aimed to seek for better approaches to automate AVD optimization.
Methods: In a study of 35 heart failure patients (27m, 8f, age: 67±8y) with Insync III Marquis CRT-D systems we recorded telemetric electrograms between left ventricular electrode and superior vena cava shock coil (LVtip/SVC = LVCE) simultaneously with LAE. By LVCE we measured intervals As-Pe in VDD and Ap-Pe in DDD operation between right atrial sense-event (As) or atrial stimulus (Ap), resp., and end of the atrial activity (Pe). As-Pe and Ap-Pe were compared with As-LA an Ap-LA in LAE, respectively.
Results: End of the left atrial activity in LVCE could clearly be recognized in 35/35 patients in VDD and 29/35 patients in DDD operation. We found mean intervals As-LA of 40.2±24.5ms and Ap-LA of 124.3±20.6ms. As-Pe was 94.8±24.1ms and Ap-Pe was 181.1±17.8ms. Analyzing the sums of As-LA + 50ms with duration of As-Pe and Ap-LA + 50ms with duration of Ap-Pe, the differences were 4.7±9.2ms and 4.2±8.6ms, resp., only. Thus, hemodynamically optimal timing of the ventricular stimulus can be triggered by automatically detecting Pe in LVCE.
Conclusion: Based on minimal deviations between LAE and LVCE approach, we proposed companies to utilize the LVCE in order to automate individual AVD optimization in CRT pacing.
本发明涉及一种用于生物阻抗测量和/或用于神经刺激的食道电极探针(10);用于经食道心脏病治疗和/或心脏病诊断的设备(100);以及一种用于控制或调节用于心脏导管消融装置和/或心脏、循环和/或肺支持装置的方法。食道电极探针包括生物阻抗测量装置,用于测量围绕食道电极探针的组织中的至少一部分组织的生物阻抗。生物阻抗装置包括至少一个第一电极和至少一个第二电极,其中至少一个第一电极(12A)布置在食道电极探针的面向心脏的一侧(14)上,并且至少一个第二电极(12B)布置在食道电极探针背离心脏的一侧(16)上。装置(100)包括食道电极探针(10)和控制和/或评估装置(30),其被配置用于从至少一个第一电极(12A)接收第一生物阻抗测量信号并从至少一个第二电极(12B)接收第二生物阻抗测量信号,并对这些信号进行比较,并且在比较的基础上产生控制信号。该控制信号可以是用于控制或调节心脏导管消融装置和/或心脏、循环和/或肺支持装置的信号。
Die transösophageale Neurostimulation ist eine neue Therapieform und könnte unter anderem zur Schmerzlinderung während einer transösophagealen Linksherzstimulation angewendet werden. Sie ist in die Kategorie der Rückenmarksstimulation (SCS) einzuordnen, die die meist verwendete Technik der Neurostimulation ist. Die derzeit auf dem Markt vorhandenen Ösophaguskatheter werden bei einer elektrophysiologischen Untersuchung mit Ablation und transösophagealer Echokardiographie zur Temperaturüberwachung eingesetzt. Das Ziel dieser Arbeit war, das vorhandene Offenburger Herzrhythmusmodell, um die Wirbelsäule zu erweitern, einen neuen Ösophagus-Elektroden- Katheter für die transösophageale elektrische Stimulation des Rückenmarks zu modellieren und mittels 3D-Computer-Simulationen auf Ihre Wirksamkeit zu untersuchen.
Um medizinische Behandlungsverfahren in der Praxis besser verstehen und anwenden zu können, gewinnt die Visualisierung der Prozesse an immer größerer Bedeutung. Durch Anwendung der Computer-Simulationssoftware CST können elektromagnetische und thermische Simulationen zur Analyse verschiedener Herzrhythmusstörungen durchgeführt werden. Eine weitere Form der Visualisierung erfolgt durch haptische, dreidimensionale Druckmodelle. Diese Modelle können mit einem generativen Herstellungsverfahren, wie z. B. einem 3D-Drucker, in kürzester Zeit hergestellt werden.
In-vivo and in-vitro comparison of implant-based CRT optimization - What provide new algorithms?
(2011)
Introduction: In cardiac resynchronization therapy (CRT), individual AV delay (AVD) optimization can effectively increase hemodynamics and reduce non-responder rate. Accurate, automatic and easily comprehensible algorithms for the follow-up are desirable. QuickOpt is the first attempt of a semi-automatic intracardiac electrogram (IEGM) based AVD algorithm. We aimed to compare its accuracy and usefulness by in-vitro and in-vivo studies.
Methods: Using the programmable ARSI-4 four-chamber heart rhythm and IEGM simulator (HKP, Germany), the QuickOpt feature of an Epic HF system (St. Jude, USA) was tested in-vitro by simulated atrial IEGM amplitudes between 0.3 and 3.5mV during both, manual and automatic atrial sensing between 0.2 and 1.0mV. Subsequently, in 21 heart failure patients with implanted biventricular defibrillators, QuickOpt was performed in-vivo. Results of the algorithm for VDD and DDD stimulation were compared with echo AV delay optimization.
Results: In-vitro simulations demonstrated a QuickOpt measuring accuracy of ± 8ms. Depending on atrial IEGM amplitude, the algorithm proposed optimal AVD between 90 and 150ms for VDD and between 140 and 200ms for DDD operation, respectively. In-vivo, QuickOpt difference between individual AVD in DDD and VDD mode was either 50ms (20pts) or 40ms (1pt). QuickOpt and echo AVD differed by 41 ± 25ms (7 – 90ms) in VDD and by 18 ± 24ms (17-50ms) in DDD operation. Individual echo AVD difference between both modes was 73 ± 20ms (30-100ms).
Conclusion: The study demonstrates the value of in-vitro studies. It predicted QuickOpt deficiencies regarding IEGM amplitude dependent AVD proposals constrained to fixed individual differences between DDD and VDD mode. Consequently, in-vivo, the algorithm provided AVD of predominantly longer duration than echo in both modes. Accepting echo individualization as gold standard, QuickOpt should not be used alone to optimize AVD in CRT patients.
Background: A disturbed synchronization of the ventricular contraction can cause a highly developed systolic heart failure in affected patients, which can often be explained by a diseased left bundle branch block (LBBB). If medication remains unresponsive, the concerned patients will be treated with a cardiac resynchronization therapy (CRT) system. The aim of this study was to integrate His bundle pacing into the Offenburg heart rhythm model in order to visualize the electrical pacing field generated by His bundle pacing.
Methods: Modelling and electrical field simulation activities were performed with the software CST (Computer Simulation Technology) from Dessault Systèms. CRT with biventricular pacing is to be achieved by an apical right ventricular electrode and an additional left ventricular electrode, which is floated into the coronary vein sinus. This conventional type of biventricular pacing leads to a reduction of the left ventricular ejection fraction. Furthermore, the non-responder rate of the CRT therapy is about one third of the CRT patients.
Results: His bundle pacing represents a physiological alternative to conventional cardiac pacing and cardiac resynchronization. An electrode implanted in the His bundle emits a stronger electrical pacing field than the electrical pacing field of conventional cardiac pacemakers. The pacing of the His bundle was performed by the Medtronic Select Secure 3830 electrode with pacing voltage amplitudes of 3 V, 2 V and 1.5 V in combination with a pacing pulse duration of 1 ms.
Conclusions: Compared to conventional cardiac pacemaker pacing, His bundle pacing is capable of bridging LBBB conduction disorders in the left ventricle. The His bundle pacing electrical field is able to spread via the physiological pathway in the right and left ventricles for CRT with a narrow QRS-complex in the surface ECG.
In cardiac resynchronization therapy (CRT) for heart failure, individualization of the AV delay is essential to improve hemodynamics and to minimize non-responder rate. In patients in sinus rhythm having additional disposition to bradycardia, optimization is necessary for both situations, atrial sensing and pacing. Therefore, echo-optimization is the goldstandard but time consuming. Unfortunately, it depends on the particular CRT systems parameter set if the resulting individually optimal AV delays can be programmed or not. Some CRT systems provide a set of AV delays for DDD operation combined with a set of the pace-sense-compensation to optimize the AV delay in DDD and VDD operation. The pace-sense-compensation (PSC) can be defined by the difference of implant-related interatrial conduction intervals in DDD and VDD operation measured in the esophageal left atrial electrogram. In a cohort of 96 CRT patients we found mean PSC of 59-35ms ranging between 0-143ms. As a consequence, allowing 10ms tolerance, AVD optimization is completely impossible in one of the two modes, VDD or DDD operation, in 34 (35%) or 5 (5%) patients with implants restricting the PSC range to 60ms or 100ms, respectively. Thus, we propose companies to provide CRT systems with programmable pace-sense- compensation between 0ms and 150ms.
Significance of new electrocardiographic parameters to improve cardiac resynchronization therapy
(2011)
Introduction: Oesophageal left heart electrogram (LHE) is a valuable tool providing electrocardiographic parameters for cardiac resynchronization therapy (CRT). It can be utilized to measure left ventricular (LVCD) and intra-leftventricular conduction delays (ILVCD) in heart failure patients to justify implantation of CRT systems. In the follow-up, LHE enables measurement of implant-related interatrial conduction times (IACT) which are the key intervals defining the hemodynamically optimal AV delay (AVD).
Methods: By TOSlim oesophageal electrode and Rostockfilter (Osypka AG, Rheinfelden, Germany), LHE was recorded in 39 heart failure patients (10f, 29m, 65±8yrs., QRS=163±21ms) after implantation of CRT systems according to guidelines. In position of maximal left ventricular deflection, LVCD and ILVCD were measured and compared with QRS width. In position of maximal left atrial deflection (LA), IACT was determined in VDD and DDD operation as interval As-LA and Ap-LA between atrial sense event (As) or stimulus (Ap), resp., and onset of LA. AVD was individualized using SAV =As-LA + 50ms for VDD and PAV=Ap-LA + 50ms for DDD operation.
Results: The CRT patients were characterized by minimal transoesophageal LVCD of 40ms but 73±20ms, at mean, ILVCD of 90±24ms and QRS/LVCD ratio of 2.4±0.6. The measured As-LA of 39±24ms and Ap-LA of 124±26ms resulted into SAV of 89±24ms and PAV of 174±26ms. In case of empirical AVD programming using 120ms for SAV and 180ms for PAV, the LHE revealed inverse sequences of LA and Vp in 4 patients (10%) during VDD and 13 patients (33%) in DDD pacing. In these patients, Vp preceded LA as IACT exceeded the programmed AVD.
Conclusion: Guideline indication of CRT systems is associated with LVCD of 40ms or more. Therefore, individual LVCD offers the minimal target interval that should be reached during left ventricular electrode placement to increase responder rate. Postoperatively, AV delay optimization respecting implant-related IACTs excludes adverse hemodynamic effects.
Electrical velocimetry to optimize VV delay in biventricular VVIR and DDD pacing for heart failure
(2011)
Introduction: VV delay (VVD) is the only parameter to hemodynamically optimize cardiac resynchronization therapy (CRT) for patients with atrial fibrillation (AF). Electrical velocimetry (EV) has been established to monitor thoracic electrical conductivity and to calculate hemodynamic surrogate parameters. We compared the response of this method to hemodynamic parameter changes between CRT patients with sinus rhythm (SR) and patients with AF.
Methods: VVD was individualized in 17 CRT patients in SR (12m, 5f, 67.0±7.2yrs.) after echo AV delay optimization and in 11 CRT patients in AF (10m, 1f, 69.8±9.6yrs.) using the Aesculon Cardiovascular Monitor (Osypka Medical, Berlin, Germany). Serial 30s EV recordings were accomplished, decreasing the VVD stepwise by 10ms from +60ms to -60ms between right and left ventricular stimulus. Optimal VVD was determined by the maximum of at least two of the three averaged parameters stroke volume (SV), cardiac output (CO) and cardiac index (CI). The response of SV, CO and CI was tested comparing their values in optimal VVD and suboptimal VVD. Suboptimal VVD was defined by optimal VVD±20ms.
Results: In all 28 patients in SR and AF, EV recordings resulted in optimal VVD. Between suboptimal and optimal mean VVD of 18.6±30.8ms between left and right ventricular stimulus, SV increased by 7.2±6.8%, CO by 7.8±7.2% and CI by 10.0±13.3% (all p<0.02). In the SR group with VVD of 18.8± 29.6ms, SV increased by 4.6±2.9%, CO by 5.0±2.9% and CI by 4.9±2.9% (all p<0.02). In the AF group with VVD of 18.2±4.0ms, SV increased by 10.4±8.9%, CO by 11.3±9.5% and CI by 16.4±18.2% (all p<0.02). Significant differences were not found between optimal VVD in SR and AF patients.
Conclusion: EV is a feasible serial method to individualize VVD in DDD and VVIR pacing for heart failure. Its response to hemodynamic changes demonstrates the value of EV for VVD fine-tuning.
Vergleich der hämodynamischen Reaktion auf VV-Delay Änderungen bei Sinusrhythmus und Vorhofflimmern
(2010)
Responder-rate in cardiac resynchronization therapy (CRT) of patients in sinus rhythm (SR) or atrial fibrillation (AF) mainly depends on accurat selection, optimal position of the left ventricular electrode and individualization of hemodynamical parameters of the implanted biventricular pacing system during follow-up. High resolution esophageal left heart electrocardiography offers a quick and semi-invasive approach to the electrical activity of left atrium and left ventricle. It was used in 62 heart failure patients in sinus rhythm and 11 in atrial fibrillation after implantation of CRT systems to compare the semi-invasive interventricular conduction delay (IVCDE) with QRS width. In all of the patients, guideline decision for CRT was linked with IVCDE of about 40ms and up. From logical point of view, IVCDE provides the minimal target interval for the left ventricular electrode placement in order to exclude non-responders. Esophageal measurement of interatrial conduction intervals in VDD and DDD pacing was utilized to individualize the AV delay and to exclude adverse hemodynamic effects.
Introduction: Cardiac resynchronization therapy (CRT) with left ventricular (LV) pacing is an established therapy for heart failure (HF) patients (P) with ventricular desynchronisation and reduced LV ejection fraction (EF). The aim of this study was to test the utilization of the transesophageal approach to measure arterial pulse pressure (PP) during LV pacing and electrical interventricular conduction delay (IVCD), to better select patients for CRT.
Methods: 32 HF patients (age 64 ± 10 years; 5 females, 27 males) with New York Heart Association (NYHA) class 2.8 ± 0.6, 27 ± 11 % LV EF and 155 ± 35 ms QRS duration were analysed with semi-invasive left cardiac pacing and electrocardiography. Esophageal TO8 Osypka catheter of 10.5 F diameter was perorally applied to the esophagus and placed in the position of maximum left atrial (LA) deflection and maximum LV deflection to measure PP with VAT or D00 pacing modes.
Results: Temporary transesophageal LV pacing was possible with VAT mode (n=16) and D00 mode (n=16) in all patients. In 15 Δ-PP-responders, PP was higher during LV pacing on than LV pacing off (78.3 ± 26.6 versus 65.9 ± 23.7 mmHg, P < 0.001) and NYHA class improved from 3.1 ± 0.35 to 2.1 ± 0.35 (P < 0.001) during 29 ± 26 month biventricular (BV) pacing follow-up (6 Medtronic and 9 Boston BV pacing devices). In 17 Δ-PP-non-responders, PP was not higher during LV pacing on than LV pacing off (61.5 ± 23.9 versus 60.9 ± 23.5 mmHg, P = 0.066). IVCD was significant longer in Δ-PP-responders than in Δ-PP-non-responders (87 ± 33 ms versus 37± 29 ms, P < 0.001).
Conclusion: Semi-invasive transesophageale LA and LV pacing with D00 and VAT mode and LV electrogram recording may be useful techniques to predict CRT improvement.
Termination of atrial flutter (AFL) is not possible in all AFL patients (P) with transesophageal left atrial pacing (TLAP) with undirected electrical pacing field (EPF) and high atrial pacing threshold. Purpose of the study was to evaluate bipo-lar transesophageal left atrial electrocardiography (TLAE) and TLAP with directed EPF for evaluation and termination of AFL with and without simultaneous transesophageal echocardiography (TEE).
Methods: AFL P were analysed using either a TO electrode with one cylindrical (CE) and three or seven hemispherical electrodes (HE) or TEE electrode with four HE (Osypka, Rheinfelden, Germany). Burst TLAP cycle length was between 200msand 50ms.
Results: AFL cycle length was 233±30 ms with mean ventricular cycle length of 540±149 ms. AFL could be terminated by rapid bipolar TLAP with directed EPF using HE-HE and CE-HE with induction of atrial fibrillation (AF), induction of AF and spontaneous conversion to sinus rhythm and direct conversion to sinus rhythm. Directed EPF was simulated with finite element method.
Conclusions: AFL can be evaluated by bipolar TLAE. AFL can be terminated with rapid TLAP with directed EPF with and without simultaneous TEE. Bipolar TLAE with rapid TLAP is a safe, simple and useful method for evaluation and termination of AFL.
Cardiac resynchronisation therapy (CRT) with biventricular pacing (BV) is an established therapy for heart failure (HF) patients with interventricular conduction delay (IVCD). The aim of the study was to evaluate transesophageal IVCD and left ventricular (LV) pacing with directed electrical pacing field (EPF) in HF patients.
Methods: HF patients were analysed with bipolar transesophageal LV electrocardiogram recording and LV pacing with constant voltage stimulus output, 4 ms stimulus duration, distal cylindrical electrode (CE) and seven 6 mm hemispherical electrodes (HE) with 15 mm electrode distance (TO, Dr. Osypka, Rheinfelden, Germany).
Results: LV electrocardiogram recording with HE-HE and CE-HE evaluated a mean IVCD of 79.9 ± 36.7 ms. Directed EPF with CE-HE and HE-HE allowed LV VAT (n=12) and LV D00 pacing (n=5) with a mean effective capture output of 97.35 ± 6.64 V. In 15 responders with IVCD of 87 ± 33 ms arterial pulse pressure (PP) increased from 65 ± 24 mmHg to 79 ± 27 mmHg (p < 0.001). EPF was simulated with finite element method.
Conclusions: Transesophageal LV electrocardiography and directed EPF pacing with CE and HE allowed the evaluation of IVCD and PP to select patients for BV pacing.
Capture threshold (CT) for transesophageal left atrial (LA) pacing (TLAP) and transesophageal left ventricular (LV) pacing (TLVP) with conventional cylindrical electrodes (CE) are higher than TLAP feeling threshold (FT). Purpose of the study was to evaluate focused TLAP CT and FT for supraventricular tachycardia (SVT) initiation and focused TLVP CT for cardiac resynchronisation therapy (CRT) simulation.
Methods: SVT initiation in patients (P) with palpitations (n=49, age 47 ± 17 years) was analysed during spontaneous rhythm and during focused bipolar TLAP with atrial constant current stimulus output, distal CE and three or seven 6 mm hemispherical electrodes (HE) (TO, Osypka AG, Rheinfelden, Germany). CRT simulation in heart failure P (n=75, age 62 ± 11 years) was evaluated by focused bipolar TLAP and/or TLVP with ventricular constant voltage stimulus output and different pacing mode.
Results: Focused electrical pacing field between CE and HE (n=28) allowed low threshold TLAP with 8.0 ± 2.6 mA CT at 9.9 ms stimulus duration (SD) which was lower than 9.2 ± 4.5 mA FT at 9.9 ms SD. Focused electrical pacing field between HE and HE (n=21) allowed low threshold TLAP with 8.1 ± 2.2 mA CT at 9.9 ms SD which was lower than 9.8 ± 5.0 mA FT at 9.9 ms SD. SVT initiation by programmed AAI TLAP was possible in 23 P and not possible in 26 P. CRT simulation was evaluated with TLAP and TLVP with VAT, D00 and V00 pacing mode and 95.5 ± 10.9 V TLVP CT at 4.0 ms SD.
Conclusions: Programmed focused AAI TLAP allowed initiation of SVT with very low CT and high FT and focused electrical pacing field between CE-HE and HE-HE.CRT simulation with focused TLAP and/or TLVP with VAT, D00 and V00 pacing mode may be a useful technique to detect responders to CRT.